BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2962152 · Received February 14, 2013

    Report

    Report Number
    1818910-2013-03903
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    December 5, 2011
    Report Date
    January 24, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LEGAL CLAIM ALLEGES THE PATIENT HAD A REVISION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. UPDATE (B)(6) 2011 - LITIGATION PAPERS RECEIVED. THEY ALLEGE THAT ON OR AROUND (B)(6) 2009, PATIENT WAS IMPLANTED WITH AN ASR HIP ON HER LEFT SIDE. PATIENT HAS EXPERIENCED INCREASED DISCOMFORT IN HER HIP AND CONTINUES TO HEAR A CRACKING SOUND WHEN SHE WALKS. BLOOD TESTS REVEAL ELEVATED LEVELS OF CHROMIUM AND COBALT IN HER SYSTEM. DUE TO HER INCREASED DISCOMFORT AND ELEVATED LEVELS OF METAL IONS, PATIENT WILL LIKELY HAVE TO UNDERGO A REVISION SURGERY. DOI: (B)(6) 2009 - DOR: UNK (LEFT SIDE). UPDATE (B)(6) 2011-PATIENT WAS REVISED DUE TO HIGH ION LEVELS. UPDATE 01/24/2013-MEDICAL RECORDS WERE OBTAINED. RECORDS INDICATE LEFT HIP. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66150 ASR UNI FEMORAL IMPL SIZE 46 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2949133

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention